Solventum is hiring a Senior Regulatory Affairs Specialist to provide strategic regulatory leadership for a portfolio of medical devices within our Infection Prevention, Surgical Solutions, and Negative Pressure Wound Technology businesses. In this remote role, you will guide product development teams to secure global market authorizations and ensure ongoing product compliance throughout the device lifecycle, collaborating with some of the best minds in healthcare.
What You'll Do
- Develop and execute regulatory strategies to achieve new product market authorizations with speed and differentiated claims.
- Manage complex decision-making among cross-functional stakeholders in a dynamic regulatory environment.
- Represent regulatory affairs in global business and functional strategic meetings and forums.
- Perform regulatory assessments and determine registration plans for strategic business implementation.
- Articulate global registration requirements and compile regulatory documents according to local regulations.
- Submit registration documents and manage all in-process evaluations until authorization is obtained.
- Act as the focal point for commercial support pertaining to all regulatory activities.
- Manage regulatory systems and tools to drive operational excellence and ensure data integrity.
- Review advertising and promotional materials to ensure alignment with cleared claims.
- Monitor new regulations and provide necessary updates and documentation to the organization.
- Support ISO 13485, Medical Device Single Audit Program, and Technical Surveillance audits.
What We're Looking For
- Bachelor’s Degree or higher AND seven (7) years of experience in Regulatory Affairs & Medical Device experience.
- OR High School Diploma/GED and eleven (11) years of experience in Regulatory Affairs & Medical Device experience.
- Three (3) years of experience with electromechanical medical devices.
- Three (3) years of experience with regulatory submissions including: 510(k) submissions, EU MDR submissions, and/or other international medical device regulations.
Nice to Have
- Bachelor’s Degree or higher in electrical engineering, mechanical engineering or software engineering/programming.
- Advanced degree in Scientific, Engineering or Regulatory/Quality.
- Five (5) years of experience with electromechanical medical devices.
- Five (5) years of experience with regulatory submissions which may include: 510(k), EU MDR, and/or other international submissions.
- Experience with temperature management, negative pressure wound devices, and/or wound care devices.
- Experience with stand-alone software devices and cybersecurity.
- Three (3) years of experience with supporting 13485 and MDSAP audits.
Benefits & Compensation
- Compensation: $131,750 - $170,500 (base pay plus variable incentive pay)
- Medical, Dental & Vision coverage
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits
Work Mode
This is a fully remote position for candidates located within the United States.
Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.
